• Register pharmaceutical products with ANVISA before placing medicines on the Brazilian market.

• Ensure packaging includes required product identification, batch numbers, and expiry information.

• Maintain batch level traceability records for manufacturing, importation, and distribution.

• Ensure distributors maintain shipment documentation that supports product traceability.

• Maintain recall readiness by ensuring batch distribution records are complete and accessible.

• Provide traceability records to ANVISA during regulatory inspections or product safety investigations.

Brazil does not operate a national pharmaceutical serialization repository or centralized track and trace reporting system.

The previously proposed SNCM platform is no longer implemented, and supply chain participants are not required to report serialization events to a national hub.

Regulatory oversight is maintained through:

Manufacturing and distribution records
Import documentation
Batch level traceability records
Product recall reporting procedures

ANVISA relies on these records during inspections and investigations.

There is no national regulatory requirement for aggregation or packaging hierarchy reporting in Brazil.

Manufacturers and distributors may use logistics identifiers such as SSCC for internal warehouse and transportation operations.

Aggregation structures may be implemented voluntarily for operational efficiency but are not mandated by regulation.

• Assuming Brazil currently requires pharmaceutical serialization or serial level traceability reporting.

• Printing serialized DataMatrix barcodes for regulatory compliance purposes when not required.

• Failure to maintain accurate batch level traceability records.

• Incomplete distribution records that prevent effective product recalls.

• Mismatch between packaging batch information and manufacturing records.